Description du projet
Une nouvelle approche pour le traitement des gliomes de haut grade
Les gliomes de haut grade (HGG pour «High-grade gliomas») sont les cancers du cerveau les plus agressifs. Le pronostic des patients atteints de HGG est mauvais, et le traitement le plus efficace, la radiothérapie, n’augmente la survie médiane que de quelques mois. La PME italienne Lisapharma vise à développer un nouveau traitement pour les HGG, y compris le glioblastome multiforme, basé sur une plateforme nanotechnologique. Le médicament comprend une dispersion pour injection contenant des nanoparticules brevetées chargées d’acide zolédronique en tant que principe actif. Comparé aux traitements actuels du cancer du cerveau, ce produit a démontré des améliorations significatives avec une efficacité plus élevée et une toxicité plus faible dans les modèles animaux. L’objectif du projet EDROMA financé par l’UE est de finaliser le produit et de développer un plan d’affaires pour son introduction sur le marché.
Objectif
Lisapharma, an Italian pharmaceutical SME, aims to bring on the market Edroma: a new product based on a nanotechnology platform to treat malignant high-grade gliomas (HGG), for which there are no satisfactory curative methods. High-grade gliomas are the most aggressive type of brain cancer. Despite recent advances in treatment, the prognosis for patients with HGG is dismal: so far the most effective treatment, radiotherapy, brings an increase in median survival from 3-4 months to around 9-10. The Edroma medicinal product is a dispersion for injection made of nanoparticles encapsulating the active ingredient zoledronic acid, resulting by a self-assembling procedure made possible by Lisapharma’s patented platform. Compared to the current brain-cancer therapy solutions, Edroma innovation brings significant improvements in terms of higher efficacy and lower toxicity. Pre-clinical tests on mice demonstrated tumour reduction, increased life-expectancy and even, in one case out of 6, complete cure. Lisapharma has obtained the orphan designation from both EMA and FDA. This represents a unique business opportunity, as Lisapharma will be the only authorised provider of the new product for 10 year (7 in USA). It is estimated that the number of treatable cases in EU and USA could reach 20,000 subjects for which there are no alternative curative therapy. Considering 15,000 € per treatment cycle, the values of this potential market approximate 135 M€, and Lisapharma intends to reach 30% of this market in 5 years. The project has the potential to boost growth of Lisapharma by increasing significantly the company turnover. The total investment required is about 4.5 M€ over 3 years, for clinical studies, equipment and industrialisation, marketing and business development, with a foreseen ROI (internal return rate) of 122%.
Champ scientifique
- medical and health sciencesbasic medicinepharmacology and pharmacydrug discovery
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesmedical biotechnologynanomedicine
- medical and health sciencesclinical medicineoncology
- engineering and technologynanotechnologynano-materials
Programme(s)
- H2020-EU.2.1.2. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies Main Programme
- H2020-EU.2.1.5. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced manufacturing and processing
- H2020-EU.2.1.3. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials
- H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Régime de financement
SME-1 - SME instrument phase 1Coordinateur
22036 ERBA
Italie
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.